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Acetaminophen versus Ibuprofen in Young Children with Mild Persistent Asthma.

Publication ,  Journal Article
Sheehan, WJ; Mauger, DT; Paul, IM; Moy, JN; Boehmer, SJ; Szefler, SJ; Fitzpatrick, AM; Jackson, DJ; Bacharier, LB; Cabana, MD; Covar, R; Ly, N ...
Published in: N Engl J Med
August 18, 2016

BACKGROUND: Studies have suggested an association between frequent acetaminophen use and asthma-related complications among children, leading some physicians to recommend that acetaminophen be avoided in children with asthma; however, appropriately designed trials evaluating this association in children are lacking. METHODS: In a multicenter, prospective, randomized, double-blind, parallel-group trial, we enrolled 300 children (age range, 12 to 59 months) with mild persistent asthma and assigned them to receive either acetaminophen or ibuprofen when needed for the alleviation of fever or pain over the course of 48 weeks. The primary outcome was the number of asthma exacerbations that led to treatment with systemic glucocorticoids. Children in both groups received standardized asthma-controller therapies that were used in a simultaneous, factorially linked trial. RESULTS: Participants received a median of 5.5 doses (interquartile range, 1.0 to 15.0) of trial medication; there was no significant between-group difference in the median number of doses received (P=0.47). The number of asthma exacerbations did not differ significantly between the two groups, with a mean of 0.81 per participant with acetaminophen and 0.87 per participant with ibuprofen over 46 weeks of follow-up (relative rate of asthma exacerbations in the acetaminophen group vs. the ibuprofen group, 0.94; 95% confidence interval, 0.69 to 1.28; P=0.67). In the acetaminophen group, 49% of participants had at least one asthma exacerbation and 21% had at least two, as compared with 47% and 24%, respectively, in the ibuprofen group. Similarly, no significant differences were detected between acetaminophen and ibuprofen with respect to the percentage of asthma-control days (85.8% and 86.8%, respectively; P=0.50), use of an albuterol rescue inhaler (2.8 and 3.0 inhalations per week, respectively; P=0.69), unscheduled health care utilization for asthma (0.75 and 0.76 episodes per participant, respectively; P=0.94), or adverse events. CONCLUSIONS: Among young children with mild persistent asthma, as-needed use of acetaminophen was not shown to be associated with a higher incidence of asthma exacerbations or worse asthma control than was as-needed use of ibuprofen. (Funded by the National Institutes of Health; AVICA ClinicalTrials.gov number, NCT01606319.).

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Published In

N Engl J Med

DOI

EISSN

1533-4406

Publication Date

August 18, 2016

Volume

375

Issue

7

Start / End Page

619 / 630

Location

United States

Related Subject Headings

  • Prospective Studies
  • Pain
  • Male
  • Kaplan-Meier Estimate
  • Infant
  • Incidence
  • Ibuprofen
  • Humans
  • General & Internal Medicine
  • Fever
 

Citation

APA
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ICMJE
MLA
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Sheehan, W. J., Mauger, D. T., Paul, I. M., Moy, J. N., Boehmer, S. J., Szefler, S. J., … NIH/NHLBI AsthmaNet, . (2016). Acetaminophen versus Ibuprofen in Young Children with Mild Persistent Asthma. N Engl J Med, 375(7), 619–630. https://doi.org/10.1056/NEJMoa1515990
Sheehan, William J., David T. Mauger, Ian M. Paul, James N. Moy, Susan J. Boehmer, Stanley J. Szefler, Anne M. Fitzpatrick, et al. “Acetaminophen versus Ibuprofen in Young Children with Mild Persistent Asthma.N Engl J Med 375, no. 7 (August 18, 2016): 619–30. https://doi.org/10.1056/NEJMoa1515990.
Sheehan WJ, Mauger DT, Paul IM, Moy JN, Boehmer SJ, Szefler SJ, et al. Acetaminophen versus Ibuprofen in Young Children with Mild Persistent Asthma. N Engl J Med. 2016 Aug 18;375(7):619–30.
Sheehan, William J., et al. “Acetaminophen versus Ibuprofen in Young Children with Mild Persistent Asthma.N Engl J Med, vol. 375, no. 7, Aug. 2016, pp. 619–30. Pubmed, doi:10.1056/NEJMoa1515990.
Sheehan WJ, Mauger DT, Paul IM, Moy JN, Boehmer SJ, Szefler SJ, Fitzpatrick AM, Jackson DJ, Bacharier LB, Cabana MD, Covar R, Holguin F, Lemanske RF, Martinez FD, Pongracic JA, Beigelman A, Baxi SN, Benson M, Blake K, Chmiel JF, Daines CL, Daines MO, Gaffin JM, Gentile DA, Gower WA, Israel E, Kumar HV, Lang JE, Lazarus SC, Lima JJ, Ly N, Marbin J, Morgan WJ, Myers RE, Olin JT, Peters SP, Raissy HH, Robison RG, Ross K, Sorkness CA, Thyne SM, Wechsler ME, Phipatanakul W, NIH/NHLBI AsthmaNet. Acetaminophen versus Ibuprofen in Young Children with Mild Persistent Asthma. N Engl J Med. 2016 Aug 18;375(7):619–630.

Published In

N Engl J Med

DOI

EISSN

1533-4406

Publication Date

August 18, 2016

Volume

375

Issue

7

Start / End Page

619 / 630

Location

United States

Related Subject Headings

  • Prospective Studies
  • Pain
  • Male
  • Kaplan-Meier Estimate
  • Infant
  • Incidence
  • Ibuprofen
  • Humans
  • General & Internal Medicine
  • Fever